AdaptiveStim Objectifying Subjective Pain Questionnaires (EMINENT)

July 12, 2017 updated by: Moens Maarten
This is a prospective, multi-center, correlation study in which the investigators aim to explore the relationship between subjective pain questionnaires and the AdaptiveStim accelerometer output.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this research is to gather the necessary information relating to the patient his subjective self-report and the more objective information from the implanted IPG (RestoreSensor). Such subjective information can be gathered from the AdaptivStim output.

The main focus of this study is to explore the relationship between the subjective reporting of functional disability with the ODI, sleep quality with the Actiwatch and PSQI, pain intensity with the NRS-diary and the objective measurement of functional positions with the AdaptiveStim in patients receiving high density spinal cord stimulation.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
        • AZ Nikolaas
    • Vlaams Brabant
      • Brussels, Vlaams Brabant, Belgium, 1090
        • UZ Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • FBSS patients treated with SCS (IPG = RestoreSensor) who achieved a steady state (steady state is considered when the parameters didn't changed for at least one month)
  • Age > 18 years

Exclusion Criteria:

  • Patients with Parkinson's disease
  • Patients immobilised due to limb/pelvis/costal fractures
  • Stroke patients with MRS>3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: spinal cord stimulation(RestoreSensor)
Other: registration of AdaptiveStim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AdaptiveStim output
Time Frame: The change between baseline (T1) and the second assessment 7 days later (T1+7days)
The Implantable Pulse Generator contains a processor and accelerometer to record objective information about 7 functional positions.
The change between baseline (T1) and the second assessment 7 days later (T1+7days)
Disability
Time Frame: Disability will be measured at the second assessment namely 7 days after the first assessment
Disability will be measured using the Oswestry Disability Index (ODI) questionnaire
Disability will be measured at the second assessment namely 7 days after the first assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS) pain diary
Time Frame: Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))
Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))
Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).
Time Frame: Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))
This compact and lightweight electronic device similar in size to a wristwatch is worn on the non-dominant hand, and measures and records sleep quality
Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))
Subjective sleep quality
Time Frame: Disability will be measured at the second assessment namely 7 days after the first assessment
Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
Disability will be measured at the second assessment namely 7 days after the first assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moens Maarten

Collaborators

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 25, 2016

First Posted (Estimate)

November 28, 2016

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMINENT1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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